Events

Recall of CryoValve, Pulmonary Valve

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Cryolife Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    30218
  • Event Risk Class
    Class 2
  • Event Number
    Z-0171-05
  • Event Initiated Date
    2004-05-06
  • Event Date Posted
    2004-11-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-06-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35426
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Heart-Valve, Allograft - Product Code MIE
  • Reason
    Cryolife conducted a retrospective review which revealed the sterilization cycle of instruments used during processing of various tissues could not be confirmed as acceptable.
  • Action
    Consignees were notified by letter on/about May 6, 2004.

Device

CryoValve, Pulmonary Valve
  • Model / Serial
    Donor #59446, Serial #7352907, Model #PV10
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Nationwide, Austria, Canada, Germany
  • Product Description
    CryoValve, Pulmonary Valve
  • Manufacturer
    Cryolife Inc

Manufacturer

Cryolife Inc
  • Manufacturer Address
    Cryolife Inc, 1655 Roberts Blvd Nw, Kennesaw GA 30144-3632
  • Source
    USFDA